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Percutaneous Endoscopic Biliary Exploration in Complex Biliary Stone Disease

Sponsor
Imam Abdulrahman Bin Faisal University (Other)
Overall Status
Completed
CT.gov ID
NCT04308993
Collaborator
(none)
15
Enrollment
247.6
Actual Duration (Months)

Study Details

Study Description

Brief Summary

Patients with complex biliary stone disease are challenging to treat. The investigator present their experience in using urological interventions to treat challenging biliary stones.

Methods:

Fifteen patients with biliary calculi underwent 21 interventions using either extracorporeal shock wave lithotripsy (ESWL), percutaneous transhepatic choledochoscopy, percutaneous transcystic choledochoscopy, or a combination of these.

Condition or Disease Intervention/Treatment Phase
  • Procedure: percutaneous transhepatic choledochoscopy

Detailed Description

The investigator conducted a retrospective review to investigate the outcomes of urological treatments for biliary calculi from January 1, 1999, to August 31, 2016, focusing on percutaneous endoscopic methods and/or ESWL. The primary outcomes of interest were symptom- and stone-free rates, length of hospital stay, and complications. Our institutional ethics review board approved the study (IRB-2018-01-119). Due to the retrospective nature of the study, the need for informed consent was waived. One endourologist evaluated all patients preoperatively.

Urological intervention techniques The three different approaches used (ESWL, PTHC, and PTCC) are described below.

Study Design

Study Type:
Observational
Actual Enrollment :
15 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Percutaneous Endoscopic Biliary Exploration in Complex Biliary Stone Disease: Cohort Study
Actual Study Start Date :
Jan 1, 1999
Actual Primary Completion Date :
Aug 31, 2016
Actual Study Completion Date :
Aug 19, 2019

Outcome Measures

Primary Outcome Measures

  1. symptoms [at least one year follow up]

    success rate of biliary stone clearance or asymptomatic derbies

Secondary Outcome Measures

  1. ultrasound [one month]

    evidence of stone clearance

Other Outcome Measures

  1. obstructive jaundice [one day]

    biochemical evidence (Liver function test) of improvement

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Inclusion Criteria:
  • complete records
Exclusion Criteria:
  • lost follow up

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Imam Abdulrahman Bin Faisal University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Hanan Mesfer Alghamdi, Assistant professor of Surgery, Imam Abdulrahman Bin Faisal University
ClinicalTrials.gov Identifier:
NCT04308993
Other Study ID Numbers:
  • IAU-PEBE
First Posted:
Mar 16, 2020
Last Update Posted:
Mar 16, 2020
Last Verified:
Mar 1, 2020
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Cholelithiasis
Cholecystolithiasis
Gallstones

Study Results

No Results Posted as of Mar 16, 2020